BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LYSUS INFUSION CATHETER

    MDR report key: 839568 · Received April 11, 2007

    Report

    Report Number
    839568
    Event Type
    Malfunction
    Date Received
    April 11, 2007
    Date of Event
    March 8, 2007
    Report Date
    April 11, 2007
    Manufacturer
    EKOS CORPORATION
    Product Code
    NUI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN EKOS LYSUS INFUSION CATHETER WAS PLACED IN THE PATIENT. FOUR HOURS LATER, THE ULTRASONIC CORE HAD FAILED. THE PATIENT WAS RETURNED TO INTERVENTIONAL RADIOLOGY WHERE THE CATHETER WAS SUCCESSFULLY REMOVED AND REPLACED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYSUS INFUSION CATHETER CATHETER, IV NUI EKOS CORPORATION 060725062-004 *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR